Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer
|ClinicalTrials.gov Identifier: NCT01118624|
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Breast Tumors Neoplasms, Breast Cancer of the Breast Human Mammary Carcinoma||Drug: Pralatrexate Injection Dietary Supplement: Vitamin B12 Dietary Supplement: Folic Acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Pralatrexate in Female Patients With Previously-treated Advanced or Metastatic Breast Cancer|
|Study Start Date :||March 2010|
|Primary Completion Date :||April 2012|
|Study Completion Date :||July 2012|
Drug: Pralatrexate Injection
- Vitamin B9
Intravenous (IV) push administration over 3-5 minutes.
Initial dose: 190 mg/m2
Dose reductions per protocol: 150 mg/m2, 120 mg/m2, and 100 mg/m2 allowed for defined toxicities.
Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.
1 mg intramuscular injection
Administered within 10 weeks prior to first dose of pralatrexate, every 8-10 weeks throughout the study and for at least 30 days after the last dose of pralatrexate.
1.0-1.25 mg orally
Administered daily for at least 7 days prior to first dose of pralatrexate, throughout the study and for at least 30 days after the last dose of pralatrexate.
- Objective Response Rate (ORR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended. ]Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.
- Duration of Response (DOR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended. ]One patient has a PR as response and duration of response was provided for that patient.
- Overall Survival (OS) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but at least every 4 weeks and no more than every 12 weeks (+/- 1 week) if treatment has ended. OS will be collected for up to 2 years from start of pralatrexate. ]Number of days from first dose of pralatrexate to death.
- Incidence of Adverse Events (AEs) and Laboratory Abnormalities [ Time Frame: Recorded at all study visits: every 2 weeks while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal). ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118624
|United States, Oregon|
|Providence Cancer Center|
|Portland, Oregon, United States, 97213|
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|Fakultní nemocnice Olomouc|
|Olomouc, Czech Republic, 775 20|
|Pardubice, Czech Republic, 532 03|
|Fakultní nemocnice Královské Vinohrady - FNKV|
|Praha, Czech Republic, 100 34|
|Centre Lutte Contre le Cancer Val d'Aurelle (CRLC)|
|Montpellier, Cedex 5, France, 34298|
|Centre Régional de Lutte Contre le Cancer Alexis Vautrin|
|Vandoeuvre, les Nancy Cedex, France, 54511|
|Centre Georges François Leclerc|
|Dijon Cedex, France, 21079|
|Centre Léon Bérard|
|Lyon Cedex, France, 69373|
|Institut Paoli Calmettes|
|Marseille, France, 13273|
|Reims Cedex 09, France, 51056|
|University of Debrecen Medical and Health Science Center|
|Debrecen, Hajdú-Bihar, Hungary, 4032|
|Semmelweis University Budapest|
|Budapest, Hungary, H-1082|
|National Health Centre of Hungary|
|Budapest, Hungary, H-1145|
|Study Director:||Garry Weems, PharmD||Spectrum Pharmaceuticals, Inc|